Defibrillation is a means of terminating ventricular fibrillation and ventricular tachycardia. The biphasic waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetry is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.

Device Description

The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not contain specific, quantifiable acceptance criteria or a direct table comparing them to reported device performance. The entire summary focuses on demonstrating "substantial equivalence" rather than meeting pre-defined performance metrics through a detailed study report.

However, based on the description, the core "performance" being highlighted is the efficacy of the Biphasic Truncated Exponential (BTE) waveform for defibrillation.

Acceptance Criteria (Implied)	Reported Device Performance
Efficacy in Defibrillation	The efficacy of the Physio-Control BTE waveform was demonstrated in a multi-site clinical study. The results of that study are reported in the 510(k). (Specific quantitative results, such as success rate or first-shock success, are not provided in this summary but are stated to be in the full K991910 submission.)
Safety	Compliance to applicable sections of ANSI/AAMI DF2 1989, Cardiac Defibrillator Devices Standard, and ANSI/AAMI DF39 1993, Automatic External Defibrillator Standard. This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.
Performance	Compliance to applicable sections of ANSI/AAMI DF2 1989, Cardiac Defibrillator Devices Standard, and ANSI/AAMI DF39 1993, Automatic External Defibrillator Standard. This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in the provided text. The document only mentions a "multi-site clinical study" for the efficacy of the BTE waveform.
Data Provenance: Not explicitly stated. It refers to a "multi-site clinical study," which generally implies prospective data collection, but no details on the specific countries or retrospective/prospective nature are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable/not mentioned. This device (a defibrillator) does not rely on human interpretation of outputs to establish ground truth in the same way an AI diagnostic tool would. The efficacy (success of defibrillation) would be measured by physiological outcomes.
Qualifications of Experts: Not applicable/not mentioned.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not mentioned. As above, this device's performance is measured by its direct physiological effect (e.g., termination of arrhythmia), not by human interpretation requiring consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a manual and automated external defibrillator/monitor/pacemaker, not an AI-assisted diagnostic tool that would improve human reader performance. Its function is to deliver therapy and monitor physiological signals.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: The core efficacy evaluation described relates to the Biphasic Truncated Exponential (BTE) waveform of the defibrillator itself, not a separate "algorithm only" performance for an interpretive component. While the device has an "Interpretive 12-lead ECG," the study described specifically addresses the defibrillation waveform. The AED mode certainly has an algorithm for rhythm analysis, but its standalone performance metrics are not detailed, beyond stating it "analyzes the patient's ECG rhythm." The clinical study mentioned focuses on the biphasic waveform efficacy.

7. The Type of Ground Truth Used:

Type of Ground Truth: For the defibrillation efficacy study, the ground truth would be clinical outcomes data related to the termination of ventricular fibrillation and ventricular tachycardia. This would likely involve observing the patient's rhythm post-shock.

8. The Sample Size for the Training Set:

Sample Size: Not applicable/not mentioned. This device's core claim (biphasic waveform efficacy) is based on fundamental physiological principles and prior clinical validation, not on a machine learning model that requires a training set in the conventional sense. While the AED component has an algorithm, no details on its training were provided.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment: Not applicable/not mentioned, as there is no explicitly defined "training set" for an AI model. For the AED algorithm, the "ground truth" for training would likely involve expert-labeled ECG rhythms (e.g., cardiologists classifying rhythms as shockable/non-shockable) if it were a machine learning algorithm. However, this is not detailed in the provided text.

Summary

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3 1999 859

510(k) Summary

Submitter's Name and Address: Medtronic Physio-Control Corp. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073

Mike Willingham, Tel. (425) 867-4329 Contact Person:

August 5, 1999 Date Summary Prepared:

Device:

Physio-Control Corporation Biphasic LIFEPAK® 12 defibrillator / monitor / pacemaker system

Classification:

Low-Energy DC - Defibrillators (including Paddles): Class II (21 CFR 870.5300)

Cardiac Monitors (including cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300)

External Transcutaneous Cardiac Pacemakers (noninvasive): Class III (870.5550)

Oximeter: Class II (21 CFR 870.2700)

Automated External Defibrillator and Interpretive 12 lead ECG: Class III

Substantial Equivalence:

The intended use and function of the Biphasic LIFEPAK 12 system are substantially equivalent to those of the:

Physio-Control LIFEPAK 12 defibrillator/pacemaker, 510(k) no. K973486.

Physio-Control LIFEPAK 500 automated external defibrillator, 510(k) no. K983393

Heartstream Forerunner defibrillator, 510(k) no. K955628.

Mine Safety defibrillator, Preamendment.

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Description:

The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and prehospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the prehospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms, etc.) and on general duty floors (e.g. medical/surgical.) It will also be used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)

Indications for Use:

Technological characteristics of new and predicate devices:

The new Biphasic LIFEPAK 12 defibrillator uses a Biphasic Truncated Exponential (BTE) waveform. The predicate LIFEPAK 12 defibrillator uses a monophasic damped sine waveform; the predicate LIFEPAK 500 and Heartstream Forerunner defibrillators use a BTE waveform: the Mine Safety defibrillator uses a biphasic exponential waveform. The pacing, 12 lead monitor, 3 lead monitor, and Pulse Oximetry features are the same as those in the original LIFEPAK 12 defibrillator.

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Summary of Performance Information:

The efficacy of the Physio-Control BTE waveform was demonstrated in a multi site clinical study. The results of that study are reported in the 510(k).

Information is also provided in the 510(k) regarding compliance to applicable sections of the following voluntary industry standards:

ANSI/AAMI DF2 1989, Cardiac Defibrillator Devices Standard .
ANSI/AAMI DF39 1993, Automatic External Defibrillator Standard ♥

This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 1999

Mr. Michael D. Willingham Vice President, Quality and Regulatory Affairs Medtronic Physio-Control Corp. 11811 Willows Road Northeast Post Office Box 97006 Redmond, WA 98073-9706

Re: K991910 LIFEPAK® 12 Biphasic Defibrillator/Monitor System Regulatory Class: III (three) Product Code: 74 MKJ, DRO, LOS, LDD, and DQA Dated: June 3, 1999 Received: June 7, 1999

Dear Mr. Willingham:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for

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Page 2 - Mr. Michael D. Willingham

devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahlan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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LIFEPAK 12 biphasic defibrillator/monitor series - Indications for Use

Defibrillator

Defibrillation therapy is used as a means of terminating ventricular fibrillation and ventricular tachycardia. The biphasic waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients. Inc device has not been evaluated for AF or for dicect cardiac defibrilate

Automated External Defibrillator feature

The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The AED mode is not intended for use on children less than eight years of age, per AHA guidelines.

Noninvasive Pacemaker

Noninvasive pacing is used as a means of treating symptomatic bradycardia and asvstole.

Electrocardiograph

3-Lead (3 wire) and 6-Lead (4 wire) ECG Monitoring:

The 3 and 4 wire ECG allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.

12-lead electrocardiogram (ECG)

The 12-lead electrocardiogram (ECG) is used to identify, diagnose, and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.

Pulse Oximetery

A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO2). It is used for monitoring patients who are at risk of developing hypoxemia.

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08/26/99

✓ PRESCRIPTION USE

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Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.